FDA 510(k)

Rastreador de ECG Asistido por IA

N.º K: K200036 · 2020-03-20

SolicitanteShenzhen Carewell Electronics Co., Ltd.

Fecha de decisión2020-03-20

Código de productoDPS

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

AI-ECG Tracker is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Carewell Electronics Co., Ltd.. It received FDA 510(k) clearance on 2020-03-20 under 510(k) number K200036. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the AI-ECG Tracker?

AI-ECG Tracker is a medical device that received FDA 510(k) clearance on 2020-03-20. The listed applicant is Shenzhen Carewell Electronics Co., Ltd.. The 510(k) number is K200036.

When did AI-ECG Tracker receive FDA 510(k) clearance?

AI-ECG Tracker received FDA 510(k) clearance on 2020-03-20, under 510(k) number K200036.

Who is the listed applicant for AI-ECG Tracker?

The FDA 510(k) record lists Shenzhen Carewell Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AI-ECG Tracker?

The FDA product code for AI-ECG Tracker is DPS.

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